Enteral Feeding Assembly

ABSTRACT

An enteral feeding system for use with a syringe or extension tubing, such as an enteral feeding syringe or tubing, is provided. The system has features to balance the pressure within the tubing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a non-provisional of U.S. Provisional PatentApplication Ser. No. 61/367,228 filed Jul. 23, 2010, entitled “EnteralFeeding Connector and Assembly”, the contents of which are fullyincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to tubing connectors and tubing,and more particularly in one aspect to an enteral feeding assemblyincluding an improved tubing designed to deal with undesired vacuum aswell as overpressure issues.

BACKGROUND OF THE INVENTION

Fluid delivery systems, such as feeding tubes, are used to delivernutrients and medicine to patients. The state of being fed by a feedingtube is known in the art as enteral feeding or tube feeding.

As an example, in a neo-natal unit, infants are often fed enterally. Atube is inserted in is the mouth or nasal opening of the infant and downthrough the esophagus for delivery of the fluid to the stomach orintestinal region of the body. In this example, breast milk or formulaare delivered by syringe into an enteral delivery system, such as anenteral tube, for delivery into the infant's stomach. However, enteralfeeding systems can also be for pediatric or adult use. Sometimes aperistaltic pump is used to deliver fluids from a feeding bag.

In the course of using the feeding tube, it is possible that anoverpressure can develop in the tube and/or the infant's stomach.Alternatively, an excessive vacuum state can exist during aspiration,where the tubing is generating an undesired suction force at theopenings in its distal tip.

SUMMARY OF THE INVENTION

An improved enteral feeding system is provided. The system comprises atube having a first end, a second end, an exterior sidewall, a conduitwithin said tube between said first end and a location near said secondend, a first orifice, and a second orifice. The second orifice islocated downstream of the first orifice, extending from a point below anend of the conduit to a point along the length of the conduit. Thishelps to alleviate certain undesired suction issues, as well as inhibitbacterial collection and growth. To prevent excessive negative pressurewithin the tubing, as at an orifice, the tubing may comprise acollapsible feature formed therein. The collapsible feature may comprisea thinned region that collapses when excessive negative pressure isapplied, effectively cutting off further negative pressure from beingexerted and giving the clinician an indication that an excessive vacuumis being applied.

A supporting structure may additionally be present on the tubing, in theform of a cage is structure. The tubing may comprise a thinned region inthe area surrounded by the cage structure that balloons out if excessivepressure is applied within the tubing.

A one-way valve may be removably attachable to a tube section, either atan end of the tube section, or along the length of the tube section.Where the one-way valve is attached to the end of the tube section,either a cap or a syringe may be pushed into the valve to send air to achannel within the valve, which then flows through the tubing. In someembodiments, one-way valves may be placed along the length of the tubesection to release pressure from within a conduit in the tubing.

In another embodiment, an enteral feeding system is provided thatcomprises a first tube section comprising a first end, a second end, anexterior sidewall, and a conduit within the first tube section thatextends from the first end to the second end. The first tube section isremovably attachable to a tubing.

These and other aspects, objects, and accomplishments of the presentinvention will be further understood upon consideration of the followingdetailed description of certain embodiments, taken in conjunction withthe below drawings depicting various embodiments, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

Various exemplary embodiments are described herein with reference to thefollowing drawings, wherein like numerals denote like parts.

FIG. 1 is a perspective view of an enteral feeding system;

FIG. 2 is an enteral feed tube with novel modifications to deal withsuction issues at the distal tip;

FIG. 3 shows a modified proximal end-structure to the tubing of FIG. 2;

FIG. 4 is an enteral feed tube section like that of FIG. 2, modified tobe retrofit to standard tubing;

FIG. 5 is an enlarged, partial view of an enteral feed tube with apressure release valve;

FIG. 6 is an enlarged, partial view of an enteral feed tube with apressure release valve;

FIG. 7A is a partial view of an enteral feed tube section with a one-wayvalve;

FIG. 7B is a top view of the one-way valve of FIG. 7A; and

FIG. 8 is an enteral feed tube with novel modifications to deal withexcessive pressure issues within the tube.

DETAILED DESCRIPTION OF THE DRAWINGS

The connector and assembly of the present invention will be describedherein for use with an enteral feeding tube, but it is contemplated thatthe connector assembly of the present invention can be used in anydevice that may benefit from this type of assembly.

FIG. 1 is a perspective view of a typical enteral feeding system 100, inaccordance with exemplary embodiments. Enteral feeding system 100 has asyringe 110 and a tube 120. Syringe 110 has a distal end 112, a proximalend 114, and a plunger 118. At proximal end 114 is a syringe tip 116.Tubing 120 has a first end 122 and a second end 124. In this system 100,first end 122 of tube 120 and syringe tip 116 may be removably securedtogether. To secure syringe tip 116 to first end 122 of tube 120,syringe tip 116 is manually inserted into first end 122 of tube 120.

FIG. 2 shows an enteral feed tube with novel modifications. Tube 800 issimilar in form to a standard enteral feed tube, but with several newfeatures. One is in the tube end 802, which is inserted into thepatient. It has been the case in standard enteral tubing that an orificeis 804 (sometimes referred to as a drainage eye), is located upstreamfrom the solid tube end 802. This leaves a volume below the eye in thetube end which can retain fluid therein. To eliminate this undesirablefluid eddy in the tube end, in which bacteria growth may occur forinstance, another orifice 806 is formed in tube end 802. This orificeextends in this embodiment from a point below where interior channel 808of the tubing ends (shown at 808′), to a point thereabove. Thus, anyfluid in the very tip of the tube end interior will have an outlet todrain, so as to eliminate the foregoing fluid eddy or trap.

In certain instances, it may be desirable to apply a suction force tothe tube 800. In order to alleviate the possibility that soft tissuemight be unintentionally pulled upon and thereby traumatized by anexcessive negative pressure, as at orifice 804, tube 800 has acollapsible feature formed therein at 812. In this embodiment,collapsible feature 812 has a thinned region 814 formed in the tubingsidewall. Thinned region 814 is designed to collapse the interior of thetubing in this area, such that thinned sidewall 814′ will substantiallycome together along the axis of the tubing, serving to cut off furtherapplication of vacuum (negative pressure) at tube end 802.

A supporting structure is provided around thinned region 814 tootherwise maintain the tubing open in normal use, except in thecircumstance when an undesirable vacuum is generated. Here, thissupporting structure takes the form of a surrounding blister, formedsurrounding the tubing sidewall. Of course, the supporting structurecould be struts, webbing, or the like which serves to maintain the partsof the tubing upstream and downstream of the thinned region 814 apart,and tubing channel 808 open in normal use. FIG. 3, for example, shows aflexible cage structure 820 which has been added to the tubing (as bypress fit, fusing, gluing, ultrasonic welding, etc.). Cage structure 820has an upper ring 821 and a lower ring 822 with ribs 824 extendingtherebetween. Cage structure 820 maintains the integrity of tubing isand the channel 808 open, except in the presence of an undesirablevacuum being applied.

Returning to FIG. 2, a cap 825 is provided to close the upstream end 801of the tubing 800. Upstream end 801 is shown here as adapted to receivethe tip of a feeding syringe for instance, or some other tip or endeffector from a device to be connected to the tubing. Cap 825 istethered to the tube 800 via tether 826. Cap 825 is useful not only inkeeping the tube closed until connection, but also in use, as whenchanging an item that is connected to the tubing.

In this same regard, the embodiment of FIG. 3 also has a tethered cap,but slightly modified. Note particularly in this embodiment that theupstream end of the enteral feeding tubing has been adapted to have aconnector structure, formed integral therewith, at least as to thesyringe/container connecting portion. As will be therefore seen, theexterior surface 210 in this area has the one or moreflanges/protuberances 220 formed thereon.

This cap 828 has a “no-touch” feature in the form of a plug 829 formedthereon, which will fit in and close interior conduit 216, with the capclosing aperture 215. A user handling the cap 828 thus need not contactthe plug 829, reducing the risk of contaminating the conduit 216. Otherno-touch features may be present on various connectors that may be usedwith the feeding system, such as those described in U.S. ProvisionalPatent Application Ser. No. 61/367,228, which is herein incorporated byreference.

FIG. 4 shows an alternative embodiment of an enteral feed tube, such asthe enteral feed tube of FIG. 2. As shown in FIG. 4, feed tube 800 isthe same as that shown in FIG. 2, but is designed to be inserted, orretrofit, to standard tubing, such as tubing first end 122 shown inFIG. 1. The FIG. 4 embodiment thus has a short tube part 803 thatterminates in a tip 807 having an opening 805. Tip 807 is sized to fitinto the standard tubing proximal end in an interference is fit, luerlock, screw fit, or the like.

FIG. 5 is an enlarged, partial view of an enteral feed tube with avacuum release valve 830. The vacuum release valve 830 shown in FIG. 5is a spring-loaded valve, and may be present on the first tube section803 to provide for vacuum release in addition to or in place of eithercage structure 820 or collapsible feature 812. Vacuum release valve 830comprises a housing 832 that extends from tubing 800. At one end ofhousing 832 is an opening 834. A spring 836 resides within housing 832,and serves to press a closure over opening 834 and opens when the vacuumwithin tubing 800 is sufficiently high. Vacuum release valve 830 may bea one-way valve, allowing for air to flow through tubing 800, and toenter housing 832 via opening 834.

FIG. 6 is an enlarged, partial view of an enteral feed tube with apressure release valve 840. The pressure release valve 840 shown in FIG.6 is an umbrella valve, and may be present on the first tube section 803to provide for pressure release in addition to or in place of eitherflexible cage structure 820 or collapsible feature 812. Pressure releasevalve 840 comprises a stem 842 and a head 844. Stem 842 is placedthrough a hole in tubing 800. Pressure release valve 840 may be aone-way valve, allowing for fluid to flow through tubing 800, and toexit housing 832 via opening 834.

FIG. 7A is a partial view of an enteral feeding tube section with aone-way valve 910 and a tethered cap 925. One-way valve 910 may beremovably attachable to tube section 122 as shown in FIG. 7A. Thus, wheneither cap 925 or a syringe is pushed into valve 910, a flexible element914 is collapsed upon itself, opening a channel into the top of thevalve 910. Cap 925 may comprise an orifice or other means to allow airinto the valve. Fluid, such as is enteral feed, may then flow into valve910 and into tubing 122, or air may be allowed to exit for venting.Valve 910 has the flexible elongate member 914 in a chamber 916.Flexible member 914 has scalloped areas 917, and is fixed at distal end918, but free to move longitudinally at proximal end 919. Proximal end919 is located within a top disk 921 of the valve structure (shown inFIG. 7B), and closes an orifice therein. When pressed by a syringe-tip,for example, proximal end moves distally, opening the orifice. When thesyringe is removed, flexible member 914 returns to its rest position,closing the orifice. Valve 910 may be a syringe valve such as thosemanufactured by Halkey Roberts, such as the 245 SERIES Swabable Valve.

FIG. 8 is an enteral feed tube with novel modifications to deal withother issues, as at the distal tip. The enteral feed tube is FIG. 8 issimilar to that of FIG. 3, and has the additional feature of thinnedregion 814, but here being designed to expand, or “balloon out” ifexcessive pressure is exerted in the tubing 800. Thus, a user candetermine simply by viewing the thinned region 814 whether too muchpressure is present within tubing 800, or within the infant's stomach.Thinned region 814 may touch cage 824 when in the extended position.Thinned region 814 may also be designed to collapse the interior of thetubing in this area if excessive vacuum pressure is applied as well, asdescribed with reference to FIG. 3.

Various exemplary embodiments and methods have been described above.Those skilled in the art will understand, however, that changes andmodifications may be made to those examples without departing from thescope and spirit of the present invention. Additional and/or differentfeatures may be present in some embodiments of the present invention.

1. An enteral feeding system comprising: a tube having a first end, asecond end, an exterior sidewall, a conduit within said tube betweensaid first end and a location near said second end; a first orifice; anda second orifice located downstream of said first orifice, wherein saidsecond orifice extends from a point below an end of said conduit to apoint along the length of said conduit.
 2. The enteral feeding system ofclaim 1, said tube further comprising a collapsible feature formed onsaid tube, said collapsible feature collapsing at least a portion ofsaid conduit within said tube when a vacuum is applied.
 3. The enteralfeeding system of claim 2, said collapsible feature comprising a thinnedregion formed in said tube exterior sidewall.
 4. The enteral feedingsystem of claim 3, said collapsible feature further comprising a issupporting structure that extends around said thinned region.
 5. Theenteral feeding system of claim 4, wherein said supporting structurefurther comprises a plurality of arms extending from said exteriorsidewall of said tubing, wherein said arms span at least the length ofsaid thinned region.
 6. The enteral feeding system of claim 4, whereinsaid supporting structure further comprises a plurality of websextending from said exterior sidewall of said tubing, wherein said websspans at least the length of said thinned region.
 7. The enteral feedingsystem of claim 4, wherein said supporting structure further comprises acage structure extending from said exterior sidewall of said tubing,wherein said cage spans at least the length of said thinned region. 8.The enteral feeding system of claim 5, wherein when a vacuum pressureapplied within said conduit is larger than a pre-designated vacuumpressure, said thinned region expands outward toward said plurality ofarms.
 9. The enteral feeding system of claim 1, said tube furthercomprising a cap attached to said tube at said first end with a tether.10. The enteral feeding system of claim 9, wherein said cap comprises aplug within the interior surface of said cap, said plug being sized andshaped to fit within and close said conduit.
 11. An enteral feedingsystem comprising: a first tube section comprising a first end, a secondend, an exterior sidewall, and a conduit within said first tube sectionand extending from said first end to said second end, said conduitdesigned to collapse upon itself and close said conduit under vacuumwithin said tube which exceeds a designated threshold; wherein saidfirst tube section is removably attachable to a tubing.
 12. The enteralfeeding system of claim 11, wherein when said first tube section isattached to said tubing, said first tube section conduit is in fluidcommunication with a conduit within said tubing.
 13. The enteral feedingsystem of claim 11, said tube further comprising a collapsible featureformed on said tube, said collapsible feature collapsing at least aportion of said conduit within said tube when a vacuum is applied. 14.The enteral feeding system of claim 13, said collapsible feature furthercomprising a thinned region formed in an exterior sidewall of said tube.15. A enteral feeding system of claim 14, said collapsible featurefurther comprising a supporting structure that extends around saidthinned region.
 16. The enteral feeding system of claim 15, wherein saidsupporting structure further comprises a plurality of arms extendingfrom said exterior sidewall of said tubing, wherein said plurality ofarms spans at least the length of said thinned region.
 17. The enteralfeeding system of claim 15, wherein said supporting structure furthercomprises a plurality of webs extending from the exterior sidewall ofsaid tubing, wherein said webs spans at least the length of said thinnedregion.
 18. The enteral feeding system of claim 15, wherein saidsupporting structure further comprises a cage structure extending fromsaid exterior sidewall of said tubing, wherein said cage spans at leastthe length of said thinned region.
 19. The enteral feeding system ofclaim 11, said tubing further comprising a one-way is valve.
 20. Theenteral feeding system of claim 19, said tube further comprising a capattached to said tube at said first end with a tether.